Device |
mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed |
Regulation Description |
Surgical mesh. |
Definition |
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy. |
Physical State |
synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape |
Technical Method |
permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus from the sacral promontory. |
Target Area |
vagina, uterus, sacrum |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Obstetrics/Gynecology |
Product Code | OTO |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
510(k)
|
Regulation Number |
878.3300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|